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Sign in to claim this brandBiotronik, Inc.
US
Last updated September 17, 2026
What Biotronik, Inc. makes
Biotronik, Inc. manufactures a range of interventional cardiovascular devices, including peripheral and coronary angioplasty balloon catheters, bare-metal and drug-eluting coronary artery stents (with bioabsorbable-polymer coatings), peripheral artery stents, and manual peripheral vascular guidewires. Notable examples include the Passeo-18 and Passeo-35 Xeo coronary stents, the Orsiro Mission drug-eluting stent, and the Pantera LEO balloon catheter.
The company’s products are regulated under FDA pathways, with devices classified as Class II, Class III, or Unclassified, and are listed via 510(k) and UDI registrations. Biotronik, Inc. is based in the United States.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does Biotronik, Inc. manufacture?
Biotronik, Inc. specializes in interventional cardiovascular devices. Their portfolio includes peripheral and coronary angioplasty balloon catheters, bare-metal and drug-eluting coronary artery stents (with bioabsorbable-polymer coatings), peripheral artery stents, and manual peripheral vascular guidewires. These devices are designed for procedures like angioplasty and stenting to treat vascular conditions.
Where is Biotronik, Inc. based?
Biotronik, Inc. is headquartered in the United States. The company’s U.S. operations support the development, manufacturing, and distribution of its cardiovascular devices globally.
Which regulatory registries list Biotronik, Inc.’s devices?
Biotronik, Inc.’s devices are listed in the FDA’s 510(k) registry and the Unique Device Identifier (UDI) database. These registries ensure compliance with U.S. regulatory requirements for medical devices, including classification and post-market surveillance.
How are Biotronik, Inc.’s devices classified under FDA regulations?
Biotronik, Inc.’s devices fall into three FDA classification categories: Class II (moderate risk, requiring special controls), Class III (high risk, requiring pre-market approval), and Unclassified (awaiting classification). The classification depends on factors like device purpose, patient risk, and intended use, determining the regulatory pathway for authorization.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- 6024 JEAN RD., LAKE OSWEGO, OR, 97035
- Website
- —
- —
- —
- —
- Phone
- —
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- 1028232
- DUNS Number
- —
Catalogue (1129)
Page 1 of 23| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Selectra Accessory Kit | K111839 | FDA 510(k) | Class II | Active |
| Passeo-35 Xeo | 10/20/170 | FDA UDI | Class II | Active |
| Passeo-35 | 5/60/80 | FDA UDI | Class II | Unknown |
| Orsiro Mission | 2.25/30/140 | FDA UDI | Class III | Active |
| Pantera LEO | 2.25/20/145 | FDA UDI | Class II | Active |
| Passeo-18 | 3/60/90 | FDA UDI | Class II | Active |
| Astron | 7/80/72 | FDA UDI | Class III | Active |
| Oscar | 3.5/20-180/127 | EUDAMEDFDA UDI | Class II | Active |
| Pulsar-18 | 5/60/90 | FDA UDI | Class III | Active |
| PK Papyrus | 3.0/26/140 | FDA UDI | Unclassified | Active |
| Passeo-35 Xeo | 5/40/130 | FDA UDI | Class II | Active |
| Orsiro | 3.5/13/140 | FDA UDI | Class III | Unknown |
| Orsiro Mission | 2.75/9/140 | FDA UDI | Class III | Active |
| Passeo-35 Xeo | 3/100/90 | FDA UDI | Class II | Active |
| Passeo-35 Xeo | 9/120/130 | FDA UDI | Class II | Active |
| Passeo-35 Xeo | 5/200/170 | FDA UDI | Class II | Active |
| Orsiro | 4.0/15/140 | FDA UDI | Class III | Unknown |
| Pulsar-18 T3 | 5/40/135 | FDA UDI | Class III | Active |
| Passeo-35 Xeo | 9/60/170 | FDA UDI | Class II | Active |
| Passeo-18 | 2.5/60/130 | FDA UDI | Class II | Active |
| Pantera LEO | 2.5/8/145 | FDA UDI | Class II | Active |
| Pulsar-18 | 6/200/135 | FDA UDI | Class III | Active |
| Passeo-35 Xeo | 7/100/90 | FDA UDI | Class II | Active |
| Orsiro | 3.5/40/140 | FDA UDI | Class III | Unknown |
| Pulsar-18 T3 | 5/120/90 | FDA UDI | Class III | Active |
| Passeo-35 Xeo | 5/40/170 | FDA UDI | Class II | Active |
| Passeo-35 | 6/170/90 | FDA UDI | Class II | Unknown |
| Pulsar-18 | 5/150/90 | FDA UDI | Class III | Active |
| Passeo-14 | 1.5/70/120 | FDA UDI | Class II | Active |
| Passeo-18 | 5/20/130 | FDA UDI | Class II | Active |
| Passeo-18 | 2/170/90 | FDA UDI | Class II | Active |
| Passeo-14 | 4/40/90 | FDA UDI | Class II | Active |
| Passeo-18 | 2.5/200/130 | FDA UDI | Class II | Active |
| Passeo-18 | 5/170/130 | FDA UDI | Class II | Active |
| Passeo-35 Xeo | 6/120/170 | FDA UDI | Class II | Active |
| Orsiro | 2.5/30/140 | FDA UDI | Class III | Unknown |
| Pulsar-18 | 5/100/135 | FDA UDI | Class III | Active |
| Passeo-35 Xeo | 8/20/90 | FDA UDI | Class II | Active |
| Pantera LEO | 2.0/8/145 | FDA UDI | Class II | Active |
| Passeo-14 | 4/140/90 | FDA UDI | Class II | Active |
| Pantera LEO | 3.25/8/145 | FDA UDI | Class II | Active |
| Passeo-35 | 10/20/80 | FDA UDI | Class II | Unknown |
| Passeo-35 Xeo | 12/40/90 | FDA UDI | Class II | Active |
| Passeo-18 | 4/150/90 | FDA UDI | Class II | Active |
| Passeo-35 | 8/40/130 | FDA UDI | Class II | Unknown |
| Pantera Pro | 3.00/10/140 | FDA UDI | Class II | Active |
| Passeo-18 | 3/80/90 | FDA UDI | Class II | Active |
| Passeo-14 | 4/70/150 | FDA UDI | Class II | Active |
| Passeo-14 | 3.5/100/150 | FDA UDI | Class II | Active |
| PRO-Kinetic Energy | 2.25/9/140 | FDA UDI | Class III | Active |
Related Companies
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FDA Recalls (42)
Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.
Biotronik, Inc. has 42 recall records initiated between February 21, 2003, and March 8, 2021, all of which are recorded as terminated. The recalls involve issues related to battery performance, including potential for reduced energy delivery, extended charge time anomalies, and premature depletion in Implantable Cardioverter Defibrillators (ICDs) and Cardiac Resynchronization Therapy Defibrillators (CRT-Ds). Additional reasons include a timing feature error, unapproved software programming for ventricular pacing, and non-compliance with U.S. approvals for certain device versions.
AI-generated summary of the recall records listed below. It describes what the records state and is not an assessment of this manufacturer.
| Date | Recall No. | Class | Status | Reason |
|---|---|---|---|---|
| Mar 8, 2021 | Z-1460-2021 | — | terminated | There is a potential for premature battery depletion in Implantable Cardioverter Defibrillators and Cardiac Resynchronization Therapy Defibrillators (CRT'Ds) |
| Mar 8, 2021 | Z-1454-2021 | — | terminated | There is a potential for premature battery depletion in Implantable Cardioverter Defibrillators and Cardiac Resynchronization Therapy Defibrillators (CRT'Ds) |
| Mar 8, 2021 | Z-1453-2021 | — | terminated | There is a potential for premature battery depletion in Implantable Cardioverter Defibrillators and Cardiac Resynchronization Therapy Defibrillators (CRT'Ds) |
| Mar 8, 2021 | Z-1464-2021 | — | terminated | There is a potential for premature battery depletion in Implantable Cardioverter Defibrillators and Cardiac Resynchronization Therapy Defibrillators (CRT'Ds) |
| Mar 8, 2021 | Z-1448-2021 | — | terminated | There is a potential for premature battery depletion in Implantable Cardioverter Defibrillators and Cardiac Resynchronization Therapy Defibrillators (CRT'Ds) |
| Mar 8, 2021 | Z-1463-2021 | — | terminated | There is a potential for premature battery depletion in Implantable Cardioverter Defibrillators and Cardiac Resynchronization Therapy Defibrillators (CRT'Ds) |
| Mar 8, 2021 | Z-1451-2021 | — | terminated | There is a potential for premature battery depletion in Implantable Cardioverter Defibrillators and Cardiac Resynchronization Therapy Defibrillators (CRT'Ds) |
| Mar 8, 2021 | Z-1457-2021 | — | terminated | There is a potential for premature battery depletion in Implantable Cardioverter Defibrillators and Cardiac Resynchronization Therapy Defibrillators (CRT'Ds) |
| Mar 8, 2021 | Z-1456-2021 | — | terminated | There is a potential for premature battery depletion in Implantable Cardioverter Defibrillators and Cardiac Resynchronization Therapy Defibrillators (CRT'Ds) |
| Mar 8, 2021 | Z-1465-2021 | — | terminated | There is a potential for premature battery depletion in Implantable Cardioverter Defibrillators and Cardiac Resynchronization Therapy Defibrillators (CRT'Ds) |
| Mar 8, 2021 | Z-1458-2021 | — | terminated | There is a potential for premature battery depletion in Implantable Cardioverter Defibrillators and Cardiac Resynchronization Therapy Defibrillators (CRT'Ds) |
| Mar 8, 2021 | Z-1459-2021 | — | terminated | There is a potential for premature battery depletion in Implantable Cardioverter Defibrillators and Cardiac Resynchronization Therapy Defibrillators (CRT'Ds) |
| Mar 8, 2021 | Z-1446-2021 | — | terminated | There is a potential for premature battery depletion in Implantable Cardioverter Defibrillators and Cardiac Resynchronization Therapy Defibrillators (CRT'Ds) |
| Mar 8, 2021 | Z-1461-2021 | — | terminated | There is a potential for premature battery depletion in Implantable Cardioverter Defibrillators and Cardiac Resynchronization Therapy Defibrillators (CRT'Ds) |
| Mar 8, 2021 | Z-1449-2021 | — | terminated | There is a potential for premature battery depletion in Implantable Cardioverter Defibrillators and Cardiac Resynchronization Therapy Defibrillators (CRT'Ds) |
| Mar 8, 2021 | Z-1441-2021 | — | terminated | There is a potential for premature battery depletion in Implantable Cardioverter Defibrillators and Cardiac Resynchronization Therapy Defibrillators (CRT'Ds) |
| Mar 8, 2021 | Z-1455-2021 | — | terminated | There is a potential for premature battery depletion in Implantable Cardioverter Defibrillators and Cardiac Resynchronization Therapy Defibrillators (CRT'Ds) |
| Mar 8, 2021 | Z-1462-2021 | — | terminated | There is a potential for premature battery depletion in Implantable Cardioverter Defibrillators and Cardiac Resynchronization Therapy Defibrillators (CRT'Ds) |
| Mar 8, 2021 | Z-1450-2021 | — | terminated | There is a potential for premature battery depletion in Implantable Cardioverter Defibrillators and Cardiac Resynchronization Therapy Defibrillators (CRT'Ds) |
| Mar 8, 2021 | Z-1443-2021 | — | terminated | There is a potential for premature battery depletion in Implantable Cardioverter Defibrillators and Cardiac Resynchronization Therapy Defibrillators (CRT'Ds) |
| Mar 8, 2021 | Z-1452-2021 | — | terminated | There is a potential for premature battery depletion in Implantable Cardioverter Defibrillators and Cardiac Resynchronization Therapy Defibrillators (CRT'Ds) |
| Mar 8, 2021 | Z-1442-2021 | — | terminated | There is a potential for premature battery depletion in Implantable Cardioverter Defibrillators and Cardiac Resynchronization Therapy Defibrillators (CRT'Ds) |
| Mar 8, 2021 | Z-1447-2021 | — | terminated | There is a potential for premature battery depletion in Implantable Cardioverter Defibrillators and Cardiac Resynchronization Therapy Defibrillators (CRT'Ds) |
| Mar 8, 2021 | Z-1445-2021 | — | terminated | There is a potential for premature battery depletion in Implantable Cardioverter Defibrillators and Cardiac Resynchronization Therapy Defibrillators (CRT'Ds) |
| Mar 8, 2021 | Z-1444-2021 | — | terminated | There is a potential for premature battery depletion in Implantable Cardioverter Defibrillators and Cardiac Resynchronization Therapy Defibrillators (CRT'Ds) |
| Jun 30, 2015 | Z-2376-2015 | — | terminated | Ventricular packing: LV software programming versions for BIOTRONIK CRT-P and CRT-D devices are recalled because they are not approved for use in the US. |
| Jan 10, 2007 | Z-1373-2008 | — | terminated | Timing Feature Error: An implementation error allows the usage of the V-V timing feature, which is not approved for use in the U.S. |
| Apr 29, 2004 | Z-0944-04 | — | terminated | Potential for device to not deliver full amount of energy |
| Apr 29, 2004 | Z-0943-04 | — | terminated | Potential for device to not deliver full amount of energy |
| Apr 29, 2004 | Z-0941-04 | — | terminated | Potential for device to not deliver full amount of energy |
| Apr 29, 2004 | Z-0942-04 | — | terminated | Potential for device to not deliver full amount of energy |
| Sep 24, 2003 | Z-0075-04 | — | terminated | Potential extended charge time anomalies. |
| Sep 24, 2003 | Z-0073-04 | — | terminated | Potential extended charge time anomalies. |
| Sep 24, 2003 | Z-0074-04 | — | terminated | Potential extended charge time anomalies. |
| Sep 24, 2003 | Z-0076-04 | — | terminated | Potential for early depletion of Implantable Cardioverter Defibrillator battery. |
| Sep 24, 2003 | Z-0077-04 | — | terminated | Potential for early depletion of Implantable Cardioverter Defibrillator battery. |
| Sep 24, 2003 | Z-0072-04 | — | terminated | Potential extended charge time anomalies. |
| Mar 21, 2003 | Z-0817-03 | — | terminated | Potential extended charge time anomalies |
| Mar 21, 2003 | Z-0816-03 | — | terminated | Potential extended charge time anomalies |
| Feb 21, 2003 | Z-0700-03 | — | terminated | Potential for battery to delivery less than full amount of energy. |
| Feb 21, 2003 | Z-0702-03 | — | terminated | Potential for battery to delivery less than full amount of energy |
| Feb 21, 2003 | Z-0701-03 | — | terminated | Potential for battery to delivery less than full amount of energy |
FDA Establishments (1)
Establishments registered with the FDA under this company group, matched by name.
- Biotronik Ag BULACH Zurich · CH FEI 3002808050